Incidence Of Bone Marrow Suppression Research Articles

Real-world safety and effectiveness of radium-223 (223Ra) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated in the US: The non-interventional REASSURE study.

5050 Background: 223Ra improved overall survival (OS) and quality of life and demonstrated a favorable safety profile in pts with mCRPC in the phase 3 ALSYMPCA trial. REASSURE (NCT02141438) is a global, prospective, single-arm, observational study of 223Ra use in pts with mCRPC and bone metastases in routine clinical practice. Here, we present clinical outcomes from the second planned interim analysis of REASSURE for pts treated in the US. Methods: This analysis included pts with confirmed mCRPC with bone metastases scheduled to receive 223Ra in the US. All pts received ≥1 dose of 223Ra. Primary endpoints are short- and long-term safety, including incidence of bone marrow suppression and second primary malignancies (SPM). Secondary endpoints included OS and pt-reported pain (Brief Pain Inventory – Short Form [BPI–SF] scores). A clinically meaningful pain response was defined as a decrease from baseline of ≥2 points in BPI-SF worst pain item. Results: Pts were enrolled from 2014–2017. Overall, 498 pts were included in this analysis. At the data cut-off (20 March 2019), the median duration of observation was 11.9 months (0.4–41.3). Most pts (81%) had bone metastases only; 69% of pts received 5–6 223Ra injections. Overall, 77% of pts had received ≥1 prior life-prolonging therapies: abiraterone (45%), enzalutamide (48%), docetaxel (25%), cabazitaxel (6%), or sipuleucel-T (24%). Concomitant enzalutamide was received by 31% of pts, and 47% received concomitant bone health agents. After 223Ra, 31% of pts received ≥1 life prolonging therapies. During treatment, 208/358 (58%) pts with a baseline BPI-SF ≥2 had a clinically meaningful pain response. Any-grade and grade ≥3 drug-related treatment-emergent adverse events (TEAEs) occurred in 32% and 10% of pts, respectively. Drug-related TEAEs resulted in 223Ra discontinuation in 4% of pts. Treatment-emergent and drug-related serious AEs (SAEs) occurred in 21% and 6% of pts, respectively. The most common (>5% of pts) any-grade drug-related TEAEs were diarrhea (10%), fatigue (9%), anemia (8%) and nausea (7%). Overall, 4% of pts had fractures; 2% of pts developed bone disorders. Eleven SPMs occurred in 10 pts (2%). In total, 60% of pts died during study follow-up. Median OS was 17.8 months (95% CI 15.6–19.4). Conclusions: Within the current treatment landscape in routine clinical practice in the US, median OS after 223Ra treatment was close to 18 months. A majority of pts completed 5–6 223Ra injections. The known safety profile of 223Ra was confirmed with no new safety signals. Over half of pts with pain at baseline had a clinically meaningful pain response during 223Ra treatment. Clinical trial information: NCT02141438 .

Clinical study of acute toxicity of pelvic bone marrow-sparing intensity-modulated radiotherapy for cervical cancer.

To compare the dose volume of the target area and the toxicity of pelvic bone marrow-sparing intensity-modulated radiotherapy (PBMS-IMRT) with routine IMRT in patients undergoing radiochemotherapy for cervical cancer. Forty patients with indications for adjuvant radiochemotherapy after cervical cancer surgery were selected and randomly divided into IMRT (n = 20) and PBMS-IMRT (n = 20) groups to observe and record the toxicity and its severity in the blood, gastrointestinal tract, and genitourinary system. There was no significant difference in the target area conformity index (CI) or homogeneity index (HI) between the two groups (p > 0.05). The pelvic bone V10-V50 in the PBMS-IMRT group were lower than those in the IMRT group (p < 0.05), and there was lower hematological toxicity (p < 0.05) and fewer delays or interruptions in chemotherapy and/or radiotherapy (p < 0.05) in the PBMS-IMRT group. The toxicity to the gastrointestinal and genitourinary systems in the two groups was not significantly different (p > 0.05). PBMS-IMRT significantly reduced the dose volume of the pelvic bone marrow, thereby reducing the incidence of bone marrow suppression. However, it had no significant impact on the gastrointestinal or genitourinary systems.

The effect of chronoradiotherapy on cervical cancer patients: A multicenter randomized controlled study.

To investigate the short-term efficacy and radiotoxicity 3.543of chronoradiotherapy in patients with cervical cancer. We also examined the overall symptom score and quality of life (QOL) of patients who underwent morning radiotherapy and evening radiotherapy. We conducted a multicenter randomized controlled trial to compare the effects of morning radiotherapy (9:00-11:00 AM) with evening radiotherapy (7:00-9:00 PM) in cervical cancer patients receiving radiotherapy. From November 2021 to June 2022, 114 cervical cancer patients admitted to eight cancer center hospitals in Tianjin, Chongqing, Hubei, Shanxi, Shandong, Shaanxi, Hebei, and Cangzhou were randomly divided into the morning radiotherapy group (MG; N = 61) and the evening radiotherapy group (EG; N = 53). The short-term efficacy of radiotherapy on cervical cancer patients at different time points and the occurrence of radiotoxicity were explored after patients had undergone radiotherapy. The total effective response (partial remission [PR] + complete remission [CR]) rate was similar across the two groups (93.5% vs. 96.3%, p > 0.05). However, the incidence of bone marrow suppression and intestinal reaction in the two groups were significantly different (p < 0.05). The patients in the MG had significantly higher Anderson symptom scores than patients in the EG (21.64 ± 7.916 vs. 18.53 ± 4.098, p < 0.05). In terms of physical activity, functional status, and overall QOL, the MG had significantly lower scores than the EG (p < 0.05). No other measures showed a significant difference between the groups. The radiotherapy effect of the MG was consistent with that of the EG. The incidence of radiation enteritis and radiation diarrhea in the MG was significantly higher than that in the EG; however, bone marrow suppression and blood toxicity in the EG were more serious than in the MG. Because of the small sample size of the study, we only examined the short-term efficacy of radiotherapy. Therefore, further clinical trials are needed to verify the efficacy and side effects of chronoradiotherapy. http://www.chictr.org.cn/searchproj.aspx, Registration Number: ChiCTR2100047140.

The positive role of traditional Chinese medicine as an adjunctive therapy for cancer.

Traditional Chinese medicine (TCM), especially Chinese herbal medicines and acupuncture, has been traditionally used to treat patients with cancers in China and other East Asian countries. Numerous studies have indicated that TCM not only alleviates the symptoms (e.g., fatigue, chronic pain, anorexia/cachexia, and insomnia) of patients with cancer and improves their quality of life (QOL) but also diminishes adverse reactions and complications caused by chemotherapy, radiotherapy, or targeted-therapy. Therefore, Chinese herbal medicines and acupuncture and other alternative therapies need to be understood by TCM physicians and other health care providers. This review mainly summarizes the experimental results and conclusions from literature published since 2010, and a search of the literature as been performed in the PubMed, MEDLINE, Web of Science, Scopus, Springer, ScienceDirect, and China Hospital Knowledge Database (CHKD) databases. Some Chinese herbal medicines (e.g., Panax ginseng, Panax quinquefolius, Astragali radix, Bu-zhong-yi-qi-tang (TJ-41), Liu-jun-zi-tang (TJ-43), Shi-quan-da-bu-tang (TJ-48), and Ban-xia-xie-xin-tang (TJ-14)) and some acupuncture points (e.g., Zusanli (ST36), Zhongwan (CV12), Neiguan (PC6) and Baihui (GV20)) that are commonly used to treat cancer-related symptoms and/or to reduce the toxicity of chemotherapy, radiotherapy, or targeted-therapy are highlighted and summarized. Through a review of literature, we conclude that TCM can effectively alleviate adverse gastrointestinal reactions (including diarrhea, nausea, and vomiting) to these anti-cancer therapies, decrease the incidence of bone marrow suppression, alleviate cardiotoxicity, and protect against chemotherapy-induced peripheral neuropathy and radiation-induced pneumonitis. Moreover, TCM can alleviate epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI)-related acneiform eruptions, diarrhea, and other adverse reactions. The hope is that this review can contribute to an understanding of TCM as an adjuvant therapy for cancer and that it can provide useful information for the development of more effective anti-cancer therapies. However, more rigorously designed trials involving cancer treatment must be conducted in the future, including complete quality control and standardized models at the cellular, organic, animal and clinical levels, in order to study TCM in multiple forms and at multiple levels.

Clinical Analysis of Docetaxel Combined with PD-1/PD-L1 Inhibitor in Second-line Treatment of Advanced Non-small Cell Lung Cancer

背景与目的程序性死亡受体1（programmed cell death 1, PD-1）/程序性死亡配体1（programmed cell death ligand 1, PD-L1）抑制剂和多西他赛作为晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）患者的标准二线治疗方案，治疗效果有限。多西他赛联合PD-1/PD-L1抑制剂是否能增加疗效并使患者更好地获益少有报道。本研究旨在探索多西他赛联合PD-1/PD-L1抑制剂二线治疗驱动基因阴性的Ⅳ期NSCLC的临床疗效和安全性。方法选取2018年10月1日-2020年12月31日在山东省肿瘤医院就诊的Ⅳ期NSCLC患者118例，依据治疗方法不同分为观察组（n=69）和对照组（n=49），观察组患者接受多西他赛联合PD-1/PD-L1抑制剂治疗，对照组患者接受PD-1/PD-L1抑制剂治疗，比较两组患者的临床疗效及3级以上不良反应发生情况。结果观察组疾病控制率（disease control rate, DCR）（89.9%）高于对照组（73.5%）（P=0.019），客观缓解率（objective response rate, ORR）（24.6%）与对照组（16.3%）比较差异无统计学意义（P=0.276）。随访至2021年6月22日，观察组中位无进展生存时间（progression-free survival, PFS）（7.17个月）长于对照组（4.43个月)（P=0.027）。观察组1年无进展生存率为15.6%，对照组为7.7%，差异无统计学差异（P=0.205）。治疗期间两组不良反应多为1级-2级，均可耐受，观察组患者骨髓抑制发生率高于对照组（P < 0.05），余不良反应与对照组无统计学差异。Cox回归分析结果显示体能状态（performance status, PS）（P=0.020）及年龄（P=0.049）是多西他赛联合PD-1/PD-L1抑制剂治疗效果的独立预后因素。结论驱动基因阴性Ⅳ期NSCLC患者应用多西他赛联合PD-1/PD-L1抑制剂二线治疗可提高疾病控制率，延长无进展生存时间，不良反应可耐受。

Management of adverse events in cancer treatment with immune checkpoint inhibitors

The use of immune checkpoint inhibitors is associated with a spectrum of immune-related adverse events related to the mechanism of action which is quite different from that of cytotoxic chemotherapy. Adverse effects can affect multiple organs of the body and are most common in the skin, gastrointestinal tract, lungs, and endocrine tissues, including the thyroid, adrenal gland, pituitary gland, as well as musculoskeletal, renal, nervous, hematologic, cardiovascular, and ocular systems. Any changes should be considered as being related to treatment with immune checkpoint inhibitors. Adverse events are very infrequent, but may be very serious and, even lethal, such as neurological disorders and myocarditis. When compared with standard chemotherapeutic agents, programmed death 1/programmed deathligand 1inhibitors are associated with a lower incidence of bone marrow suppression, anorexia, nausea, vomiting, and diarrhea. Immune checkpoint inhibitor therapy can usually continue in the presence of mild immune-related adverse events with close monitoring. However, moderate to severe immune-related adverse events may be associated with a severe decline in organ function and quality of life, and may result in fatal outcomes. Hence, these toxicities require early detection and proper management. The management of immune-related adverse events usually involves corticosteroid therapy or the use of immunomodulators. The use of immune checkpoint inhibitors in patients with preexisting autoimmune disease or a history of prior organ transplant should include careful consideration and a robust discussion of potential risks and benefits.

Comparison of the Curative Efficacy of Elderly Patients with High-Risk MDS and MDS-Transformed AML between Decitabine Combined with Low-Dose CEG Regimen and Decitabine Combined with Low-Dose CAG Regimen

To evaluate the efficacy of decitabine combined with low-dose CEG regimen (DCEG) and decitabine combined with low-dose CAG regimen (DCAG) in the treatment of elderly patients with MDS and MDS-transformed acute myeloid leukemia (AML). A prospective study was conducted in 7 medical centers, 45 patients with MDS (≥ 60 years old) and MDS-transformed AML from October 2016 to January 2019 were enrolled, with the median age of 68.5 years old. The risk stratification of patients was poor or very poor, according to IPSS-R score. The treament results of decitabine combined with CEG and decitabine combined with CAG were compared. The comparison of the two regiem showed that the DCEG regimen had advantages on total effective rate (ORR, 86.4% vs 47.8%, respectively), overall survival time (OS) (10.0 months vs 6.0 months, respectively) and progression-free survival time (PFS) (9.0 months vs 3.0 months, respectively). About 50% of MDS patients treated by DCEG regimen achieved PR or CR, with a median OS of 31 months. Multivariate analysis showed that patients with PR or CR after induction therapy and DCEG regimen had longer survival time (31months). The incidence of bone marrow suppression, infection and treatment-related mortality rate were similar between the two groups. Decitabine combined with CEG regimen could improve the survival of patients with high-risk MDS and MDS-transformed AML. The conclusion of the reaserch needs to be validated by a larger prospective randomized clinical trial.

Evaluation of IgG, IgM, CD4+ and CD8+ T cells during neoadjuvant chemotherapy with Tezio and Apatinib in gastric cancer patients

This experiment was carried out to study the effect the neoadjuvant chemotherapy with Tezio and Apatinib on the treatment of advanced gastric cancer and its impact on the postoperative immune function of patients' function. The patients with advanced gastric cancer who were treated in gastrointestinal surgery in our hospital from January 2017 to December 2018 were divided into two groups. The new chemotherapy and the traditional chemotherapy groups. The new chemotherapy group received neoadjuvant chemotherapy of Tezio combined with Apatinib before surgery, and the control group received the traditional first-line chemotherapy regimen of oxaliplatin combined with capecitabine. During the chemotherapy, the adverse complications of the two groups of patients were recorded, and the RECIST1.1 evaluation system was used to evaluate the chemotherapy effect of the patients after chemotherapy. At the same time, the R0 resection rate of the two groups of patients with gastric cancer radical surgery was recorded and compared. The fasting venous blood of the patients was collected before the chemotherapy, after the end of chemotherapy, and one week after the operation. The content of immunoglobulin G and M (IgG and IgM) was measured. The flow cytometry was used to detect CD4 + T cells and CD8+ T cells. A total of 64 patients were enrolled in this study, including 26 patients in the new chemotherapy group. Chi-square test showed that the incidence of bone marrow suppression (Leukopenia, thrombocytopenia and anemia) and liver dysfunction in the new chemotherapy group were lower than that in the traditional chemotherapy group (all P &lt;0.05), but the surgical R0 resection rate in the new chemotherapy group was higher than that in the traditional chemotherapy group (P &lt;0.05). Wilcoxon rank-sum test and chi-square test found that the chemotherapy effect of the new chemotherapy group was better than that of the traditional chemotherapy group, and the results of repeated measures analysis of variance showed that the IgG, IgM and CD4+/CD8+ T cell ratios of the patients in the new chemotherapy group were higher than that of traditional chemotherapy group (all P &lt;0.05). Apatinib combined with Tezio's preoperative neoadjuvant chemotherapy can improve the chemotherapy effect of advanced gastric cancer, increase the rate of surgical R0 resection, and reduce the patient's immunosuppressive status during treatment.

Clinical Efficacy of Low-Dose Bortezomib-BasedTriple Combination Therapy in the Treatment of Elderly Multiple Myeloma

To investigate the clinical efficacy and safety of low-dose bortezomib-basedtriple combination therapy in the treatment of elderly multiple myeloma(MM). Fifty-eight patients with elderly multiple myeloma were selected. And according to the drug rigimen the patients were randomly divided into three groups. Group A: patients received low-dose bortezomib(0.7mg/m2) on day 1, 4, 8 and 11; cyclophosphamide (0.5 g/m2) d 1, d 8; dexamethasone d 1-2,d 4-5, d 8-11, d 11-12. Group B: patients received bortezomib (1.3 mg/m2) on day 1, 4, 8 and 11; cyclophosphamide (0.5 g/m2) d 1, d 8; dexamethasone d 1-2, d 4-5, d 8-11, d 11-12. Group C: patients received bortezomib(0.7 mg/m2) on day 1, 4, 8 and 11; dexamethasone d 1-2, d 4-5, d 8-11, d 11-12. All patients in three groups were treated for 4 circles. The efficacy and response of the three groups were compared. The complete remission (CR) rate in the three groups was 31.58%, 38.09% and 27.78%. And the overall response (ORR) rate of the three groups was 68.42%, 66.67% and 55.56%, there was no statistical difference among the three groups (P＞0.05). The Hb level in MM patients with anemia after treatment was higher than the basic value. There were no statistical differences in percapita red blood cell transfusion, the incidence of bone marrow suppression and infection during 4 courses treatment among 3 groups, but the incidence of peripheral neuropathy, gastrointestinal reaction and herper zoster in group A was significantly lower than that in group B and C, moreover there was statistical difference. After the follow-up for 1 year, there was no significant difference in the survival rate among 3 groups. The efficacy of low dose bortezomib-based triple combination therapy for the patients with elderly multiple mycloma is same efficacy as of standard dose bortezomib-based triple combination therapy, but the incidence of perpheral neuropathy, gastrointestinal reaction and herper zoster is lower, the patients have better torelonce to low dose bortezomib-based triple combination therapy regimen, suggesting that this therapy possesses the efficacy of less adverse reactions and more high safety in treatment of patients with elderly muitipe myelome.

Clinical observation of LOP chemotherapy combined with radiotherapy in the treatment of early nasal NK/T cell lymphoma

Objective:To investigate the efficacy and safety of LOP（asparaginase + vincristine + dexamethasone） chemotherapy combined with radiotherapy in patients with nasal NK/T cell lymphoma. Method:Sixty patients with nasal NK/T cell lymphoma admitted to our hospital from February 2012 to February 2016 were selected as the study subject. They were randomly divided into group A and group B, 30 cases in each group. All patients were treated with combined chemotherapy and IMRT（intensity modulated conformal radiotherapy）. The LOP regimen was used in group A and the CHOP（cyclophosphamide + pirarubicin + vincristine + dexamethasone） regimen was used in group B. The short-term efficacy, long-term efficacy and adverse reactions of the two groups were compared. Result:The clinical manifestations of 60 patients mainly included nasal obstruction（81.67%）, accompanied by fever, headache, nosebleed and runny nose. Forty-one patients（68.33%） had only one site of lesion, and 21 patients（35.00%） had multiple sites of lesions. In terms of total remission rate, it was significantly higher in group A than that in group B（93.33% vs. 66.67%, P<0.05）. In terms of adverse reactions, the incidence of bone marrow suppression, gastrointestinal reaction and low-protein reaction was significantly lower in group A than that in group B（P<0.05）. Three patients died in group A and 11 patients died in group B during the 3-year follow-up. The 3-year survival rate of group A was higher than that of group B（P<0.05）. Conclusion:Compared with CHOP+IMRT regimen, the LOP+IMRT regimen for nasal NK/T-cell lymphoma patients resulted in higher overall remission rate, survival rate and lower adverse reactions, so it is worth in clinical promotion.

220.6: Effective radiation dose and bone marrow radiation exposure as a result of radiological investigation in a cohort of multivisceral transplant patients

Introduction: A patient who experienced a rare form of leukaemia following multivisceral transplantation prompted an investigation of cumulative radiation exposure due to radiological investigations in a cohort of multivisceral transplant patients from our centre. In addition, bone marrow dosimetry was calculated in view of the high incidence of bone marrow suppression in this group of patients. Methods: Dose data for CT examinations was retrospectively collected using PACS. Effective doses for each phase of each scan were estimated using 2016 updated conversion coefficients. The total number of scans and total effective dose were calculated for each patient and the stochastic risks for general cancer risk of 4.1%/Sv and leukaemia risk of 0.63%/Sv stated by the International Commission on Radiological Protection (ICRP) were estimated. Bone marrow dose per Dose-Length-Product (DLP) conversion factors were created for each anatomical region using the ImPACT Calculator, which allowed total bone marrow doses to be estimated for each patient. Bone marrow dose rates were compared against the acute radiation dose rate threshold for reduced haematopoiesis of 0.25–0.5 Gy/year suggested by the ICRP. Results: Radiation doses were calculated for 80 patients undergoing multivisceral transplant procedures (+/- liver) at Addenbrooke’s Hospital, Cambridge UK between 1998 and 2018. The average age was 49 years (range 16 – 61). The majority of the radiation dose was incurred by CT scans – 1700 in total over an average of 4.4 years per patient (SD 2.6yrs). Mean number of scan phases per patient was 33.7 (SD 17.8). Maximum number of scan phases for one patient was 83. Mean effective dose was 291 mSv (SD 224 mSv), Maximum effective dose was 1057 mSv (4.3% general cancer risk, 1.1% Leukaemia risk). 5 patients received cumulative doses in excess of 800mSv and 2 exceeded 1Sv. The highest bone marrow dose was 0.66Gy, 0.4Gy/month. 74 patients exceeded the ICRP recommended limit of 0.02 Gy/month and 11 exceeded 0.25 Gy/year and 11 patients exceeded the monthly threshold for >120 days. Conclusions: Significant radiation exposure is experienced by this cohort of patients and the threshold dose rate for reduced haematopoiesis is often exceeded with significant potential implications for the development of cancer and bone marrow suppression.

Comparison of efficacy and safety between late-course and simultaneous integrated dose-increasing intensity-modulated radiation therapy for cervical cancer complicated with pelvic lymph node metastasis

Abstract Objective This study aimed to compare and analyze the clinical efficacy and safety of late-course and simultaneous integrated dose-increasing intensity-modulated radiation therapy (IMRT) for cervical cancer complicated with pelvic lymph node metastasis. Methods Sixty patients with cervical cancer complicated with pelvic lymph node metastasis who were admitted to our hospital from January 2013 to January 2015 were enrolled. The patients were randomly divided into the late-course dose-increasing IMRT group and the simultaneous integrated dose-increasing IMRT group, with 30 cases included in each group, respectively. All patients were concurrently treated with cisplatin. After treatment, the clinical outcomes of the two groups were compared. Results The remission rate of symptoms in the simultaneous integrated dose-increasing IMRT group was significantly higher than that in the late-course dose-increasing IMRT group (P &lt; 0.05). The follow-up results showed that the overall survival time, progression-free survival time, and distant metastasis time of patients in the simultaneous integrated dose-increasing IMRT group were significantly longer than those in the late-course dose-increasing IMRT group (P &lt; 0.05). The recurrent rate of lymph nodes in the radiation field in the simultaneous integrated dose-increasing IMRT group was significantly lower (P &lt; 0.05) than in the late-course dose-increasing IMRT group. There was no significant difference in the incidence of cervical and vaginal recurrence and distant metastasis between the two groups (P &gt; 0.05). The radiation doses of Dmax in the small intestine, D1cc (the minimum dose to the 1 cc receiving the highest dose) in the bladder, and Dmax in the rectum in the simultaneous integrated dose-increasing IMRT group were significantly lower (P &lt; 0.05) than in the late-course dose-increasing IMRT group. There was no significant difference in intestinal D2cc (the minimum dose to the 2 cc receiving the highest dose) between the two groups (P &gt; 0.05). The incidence of bone marrow suppression in the simultaneous integrated dose-increasing IMRT group was significantly lower (P &lt; 0.05) than in the late-course dose-increasing IMRT group. Conclusion The application of simultaneous integrated dose-increasing IMRT in the treatment of cervical cancer patients complicated with pelvic lymph node metastasis can significantly control tumor progression, improve the long-term survival time, and postpone distant metastasis time with high safety.

Prospective Clinical Study of Capecitabine plus Oxaliplatin Concurrent Chemoradiotherapy after Radical Resection of Rectal Cancer

To investigate the efficacy and safety of concurrent chemoradiotherapy with capecitabine or oxaliplatin in locally advanced (T3-4 / N + M0) rectal cancer. A total of 56 patients with rectal cancer after radical operation were randomly divided into group A: capecitabine + oxaliplatin concurrent chemoradiotherapy group (Cap-Oxa-CRT trial, 30 cases), group B: capecitabine concurrent chemoradiotherapy group (Cap-CRT trial as Control group, 26 cases), both groups were given pelvic radiotherapy DT50.4Gy/28f/6 weeks. The two groups received adjuvant chemotherapy after concurrent CRT. (1) The 3-year overall survival rate, 3-year local recurrence rate and 3-year distant metastasis rate were not significantly different between the two groups (P> 0.05). (2) The incidence of grade 1-2 acute toxicity in group A during concurrent CRT was significantly higher than that in group B, the difference was statistically significant (P <0.05). Grade 3 toxicities were not statistically significant between the two groups (P> 0.05). No grade 4 toxicity was found in both groups. The incidences of interrupted or suspend concurrent chemotherapy in both groups were 19.23% and 46.67%, respectively, P <0.05. The incidences of interruption or suspension of radiotherapy were 11.54% and 30% respectively (P> 0.05). The completion rate of adjuvant chemotherapy in group B was higher than that in group A, but the difference was not statistically significant (P> 0.05). In postoperative adjuvant chemotherapy, the incidence of bone marrow suppression in group A was higher than that in group B (P <0.05), and the incidence of non-hematologic adverse reactions was similar between the two groups. Capecitabine combined oxaliplatin concurrent CRT, and oxaliplatin concurrent CRT have a good effect for treatment of patients with locally advanced rectal cancer after radical resection of rectal cancer. However, group A failed to further improve the curative effect, and its grade 1-2 toxicity increased significantly.

PS02.099: EFFORTS IN PROPHYLAXIS OF FEBRILE NEUTROPENIA IN DCF THERAPY FOR ESOPHAGEAL CANCER

Abstract Background DCF therapy (5-FU + CDDP + Docetaxel) for esophageal cancer is known to have strong anti-tumor effect but the incidence of bone marrow suppression (BMS) and febrile neutropenia (FN) after DCF therapy has been frequent and patients is often forced to reduce the dose of anti-cancer drug or discontinue of chemotherapy. We clarified the influence of prophylactic administration of a long-acting G-CSF, pegfilgrastim, in DCF therapy for esophageal cancer on the incidence of adverse events and anti-tumor effect. Methods From March, 2011 to July, 2017, 87 patients underwent DCF therapy (Docetaxel 60mg/m2 D1, CDDP 60mg/m2 D1, 5-FU 800mg/m2 D1–5) for esophageal squamous cell carcinoma above cStage II (33 patients administered pegfilgrastim, P group; 54 patients without pegfilgrastim, N group). We investigated the influence of pegfilgrastim on the incidence of adverse events in both groups according to CTCAE v4.0 grading system. And we investigated anti-tumor effects assessed by image examination in all patients and 47 surgically resected specimens. Results The incidence of leukocytopenia and neutropenia in P group were significantly lower than that in N group (15.2% vs 57.4%, P &lt; 0.001; 21.2% vs 64.8%, P &lt; 0.001, respectively). The incidence of FN in P group tended to be lower than that in N group (9.1% vs 20.4%, P = 0.233). Significantly more patients in N group suffered dose reduction or discontinuation of chemotherapy due to BMS or FN (30.3% vs 72.2%, P &lt; 0.001). Relative dose intensity of 5-FU in P group was significantly higher than that in N group (95.6% vs 82.5%, P = &lt; 0.001). In endoscopically evaluated response after 2 courses of DCF therapy, the reductive effects in the patients in P group significantly better than in those in N group (PR &lt; ; 78.1% vs 44.0%, P = 0.002). The overall response rate was also significantly better in the patients in P group than in those in N group (PR &lt; ; 60.6% vs 35.2%, P = 0.021). Histopathological responses in surgically resected tumor in P group tended to be better than N group (Grade 1b &lt; ; 47.1% vs 33.3%, P = 0.352). Conclusion DCF chemotherapy with prophylactic administration of pegfilgrastim may be an option for safe and effective chemotherapy for advanced esophageal cancer. Disclosure All authors have declared no conflicts of interest.

Prospective clinical study of capecitabine plus oxaliplatin concurrent chemoradiotherapy after radical resection of rectal cancer

BackgroundTo investigate the efficacy and safety of concurrent chemoradiotherapy with capecitabine or oxaliplatin in locally advanced (T3-4/N + M0) rectal cancer.Methods56 patients with rectal cancer after radical operation were randomly divided into CAPE-OX-CRT group: capecitabine + oxaliplatin concurrent chemoradiotherapy (30 cases), CAPE-CRT group: capecitabine concurrent chemoradiotherapy (control, 26 cases).ResultsThe incidence of grade 1–2 acute toxicity in CAPE-OX-CRT group during concurrent CRT was significantly higher than that in control group, the difference was statistically significant (P < 0.05). Grade 3 toxicities were not statistically significant between the two groups (P > 0.05). No grade 4 toxicity was found in both groups. The incidences of interrupted or suspend concurrent chemotherapy in both groups were 19.23% and 46.67%, respectively, P < 0.05. The incidences of interruption or suspension of radiotherapy were 11.54% and 30% respectively (P > 0.05). The completion rate of adjuvant chemotherapy in control group was higher than that in CAPE-OX-CRT group, but the difference was not statistically significant (P > 0.05). In postoperative adjuvant chemotherapy, the incidence of bone marrow suppression in CAPE-OX-CRT group was higher than that in control group (P < 0.05), and the incidence of non-hematologic adverse reactions was similar between the two groups.ConclusionCapecitabine combined oxaliplatin concurrent CRT, and oxaliplatin concurrent CRT have a good effect for treatment of patients with locally advanced rectal cancer after radical resection of rectal cancer.

An update on Chinese herbal medicines as adjuvant treatment of anticancer therapeutics.

Numerous studies have indicated that in cancer treatment Chinese herbal medicines in combination with chemo-, radio-, or targeted-therapy can be used to enhance the efficacy of and diminish the side effects and complications caused by these therapies. Therefore, an understanding of Chinese herbal medicines is needed by physicians and other health care providers. This review provides an update on Chinese herbal medicines as adjuvant treatment of anticancer therapeutics. First, some Chinese herbal medicines (e.g. Astragalus, Ginseng, Scutellaria barbata, TJ-41, TJ-48, PHY906, Huachansu injection, and Kanglaite injection) that are commonly used for treating the cancer and/or reducing the toxicity induced by chemo-, radio-, or targeted-therapy are discussed. These Chinese herbal medicines have been shown to possess great advantages in terms of suppressing tumor progression, increasing the sensitivity of chemo-, radio-, or targeted-therapeutics, improving an organism's immune system function, and lessening the damage caused by these therapeutics. Second, some clinical trials using Chinese herbal medicines as adjuvant improving cancer treatment related side effects and complications are reviewed. Some Chinese herbal medicines have a significant effect on reducing cancer-related fatigue and pain, improving peripheral neuropathy and gastrointestinal side effects including diarrhea, nausea, and vomiting, decrease the incidence of bone marrow suppression, protecting anthracycline-induced cardiotoxicity and radiation-induced pneumonitis, and relieving EGFR-TKIs related acneiform eruptions and other side effects. This review of those medicines should contribute to an understanding of Chinese herbal medicines as adjuvant treatment for cancer and provide useful information for the development of more effective anti-cancer drugs. However, rigorously designed trials on potential Chinese herbal medicine must be further examined involving cancer treatment especially molecular targeted-therapy in the future.

Challenges with Intestine and Multivisceral Re-Transplantation: Importance of Timing of Re-Transplantation and Optimal Immunosuppression.

BackgroundPatients undergoing re-transplantation often receive high doses of immunosuppression, which may lead to an immunocompromised status of the recipient. This study investigates the outcomes after intestine/multivisceral re-transplantation.Material/MethodsClinical outcomes of 23 patients undergoing 24 re-transplantations at a single intestine transplant center were reviewed. Bone marrow suppression was used as a surrogate marker of immunocompromised status, and was defined as platelet count <50 k/mm3 and absolute lymphocyte count <200/mm3.ResultsAll re-transplants except one were liver inclusive. Fifteen of 23 patients died at a median time of 12 months (range 0.2–75) after re-transplantation. Of the 15 deaths, nine (60%) resulted from complications associated with a compromised host immune status: graft versus host disease (GVHD) affecting bone marrow (three cases), persistent viral infection (three cases), post-transplant lymphoproliferative disorder (PTLD (one case), metastatic cancer (one case), multi-drug resistant polymicrobial sepsis (one case). Four deaths (27%) resulted from severe rejection. Non-survivors were more likely to have received alemtuzumab, and had higher incidence of bone marrow suppression. In addition to immunocompromised status and rejection, the use of alemtuzumab was associated with mortality after intestinal/multivisceral re-transplantation.ConclusionsHigh mortality was associated with intestine/multivisceral re-transplantation. To improve clinical outcomes of intestine and multivisceral transplantation, it is important to allow reconstitution of host immunity. Longer interval between the two transplantations, and strategies such as allograft specific immunosuppression, may spare the host from the devastating effects of potent immunosuppression currently used.

Evidence of elemene injection combined radiotherapy in lung cancer treatment among patients with brain metastases: A systematic review and meta-analysis.

Background:This review evaluates the effectiveness and safety of elemene injection combined radiotherapy in the treatment of lung cancer with brain metastases.Methods:A systematic literature research was conducted from EMBASE, Cochrane Library, PubMed, Chinese biomedical database, Chinese scientific journal database, China knowledge resource integrated database, and WanFang Database from established to July 2016 without language restriction. The Cochrane Collaboration tool was used to evaluate the risk of bias. All statistical analyses were conducted with STATA (version 14.0) and RevMan (version 5.3).Results:Eleven randomized controlled trials (765 patients) were included for determining the effectiveness and safety of elemene combined with radiotherapy in the treatment of lung cancer with brain metastases. Objective response rate (ORR) [odds ratio (OR) = 2.89, 95% confidence interval (95% CI) 2.04–4.08, P < .00001] and symptoms (OR = 4.06, 95% CI 2.00–8.25, P = .0001) improved more in the elemene-based combination treatment group than in the radiotherapy-alone control group. The Karnofsky Performance Status (KPS) score was used to measure patients’ improvement rate. The patients who were treated with elemene-based combination with radiotherapy were higher than those patients who were treated with radiotherapy alone (OR = 3.51, 95% CI 2.20–5.61, P < .00001]. The incidence of bone marrow suppression (OR = 0.27, 95% CI 0.11–0.68, P = .006) and leukopenia (OR = 0.23, 95% CI 0.12–0.46, P < .00001) decreased in the elemene-based combination treatment group by radiotherapy significantly.Conclusions:The elemene injection combined radiotherapy in the treatment of lung cancer with brain metastases appears to improve the treatment response rate and alleviated symptoms. The combined treatment has showed positive impact to reduce adverse reactions and improve quality of life.

Aplastic anemia in a lung adenocarcinoma patient receiving pemetrexed

Pemetrexed (PEM) is an antimetabolite drug that interferes with enzymes involved in DNA synthesis and also the folate-dependent metabolic processes necessary for DNA replication and homocysteine homeostasis. Continuation maintenance with PEM after induction therapy with PEM plus cisplatin has been the standard form of first-line chemotherapy for advanced non-squamous non-small cell lung cancer. The regimen has a low incidence of bone marrow suppression, and the incidences of anemia, leukopenia, neutropenia and thrombocytopenia exceeding grade 3 are less than 5%. Here we report a 68-year-old Japanese man with stage IIIB (cT4N3M0) lung adenocarcinoma who received 4 cycles of chemotherapy with PEM 500 mg/m2 and cisplatin 75 mg/m2 every three weeks, which resulted in a partial response, and then continued to receive maintenance PEM monotherapy. After 11 cycles of PEM maintenance therapy, the patient's platelet count decreased, and progressed to pancytopenia within two months. A bone marrow puncture revealed replacement with fatty marrow. As other diseases possibly responsible for pancytopenia were ruled out, we diagnosed the patient as having aplastic anemia. This is the first reported case of aplastic anemia to have occurred during PEM therapy. Clinicians should bear in mind that PEM can potentially trigger severe pancytopenia, including aplastic anemia.

The effect and clinical efficacy of lienal polypeptide injection combined with FOLFOX chemotherapy regimen in colon cancer patients.

The aim was to investigate the clinical efficacy and immunomodulatory effect of lienal polypeptide injection combined with postoperative FOLFOX chemotherapy regimen in colon cancer patients. A total of 84 colon cancer patients were selected between January, 2014 and December, 2015. The selected patients were randomly divided into the observation (42 patients) and control (42 patients) groups. The observation group patients were treated with FOLFOX chemotherapy regimen combined with lienal polypeptide, whereas, the control group patients were treated with FOLFOX chemotherapeutic regimen only. After two cycles of treatment, Karnofsky performance scale (KPS) index, side effects or toxicity and the peripheral blood T-cell subset analyses in the two groups of patients were evaluated. The patients who received FOLFOX chemotherapeutic regimen combined with lienal polypeptide in the observation group showed significantly higher score of KPS than patients of the control group (P<0.05). No significant difference in the spectrum of side effects such as nausea, vomiting, neurotoxicity, liver and kidney dysfunction, oral mucosal inflammation were observed in the treatment groups. However, the incidence of bone marrow suppression was significantly lower in the observation group in comparison with the control group (P<0.05). Additionally, the CD8+ T cells were decreased in the observation group patients compared to the control group, while the ratio of CD4+ T/CD8+ T (TH/TC) cells and the number of natural killer cells were higher in the observation group patients than the control group (P<0.05). In conclusion, the results suggest that, when the standard FOLFOX chemotheraputic regimen is combined with lienal polypeptide to treat colon cancer, it enhances the general well being of patients and strengthens the immune system in the combat against cancer.